Are Antibacterial Soaps Safe? FDA Wants Proof

In response to growing concerns about possible harms from the chemicals in antibacterial soaps, toothpaste, and other products, the U.S. Food and Drug Administration (FDA) on Monday proposed a rule that would require manufacturers to demonstrate that the substances are safe or else take them out of the products.

In announcing the new rule, the FDA said there is no evidence that antimicrobial soaps are more effective than plain soap and water in preventing infection, but accumulating scientific information prompted the agency to re-evaluate whether these chemicals are safe for daily use over long periods of time. The Times reports that soap manufacturers would not have to pull antimicrobial products from the market immediately: companies have a year to prove that the chemicals are safe and effective. The proposed FDA rule is open for public comment for 180 days. The rule does not apply to hand sanitizers, which will be evaluated separately.

Public health experts have long warned that these chemicals could scramble hormones in children and promote drug-resistant infections, a major concern in hospitals and health care settings, The New York Times reports. Experts have urged the FDA to regulate antimicrobial chemicals. But manufacturers of antimicrobial products argue that the substances have long been proved safe.

Antimicrobial chemicals were originally used by surgeons in hand washing before operations, but in recent years their use has proliferated as manufacturers added them not only to hand soaps but also to mouthwash, laundry detergent, fabrics, and even baby pacifiers. Studies in animals have demonstrated that triclosan and triclocarban (in liquid soaps and bar soaps, respectively) can disrupt metabolism and the normal development of the reproductive system. Health experts warn that the chemicals could have the same effect in humans, according to the Times. The Centers for Disease Control and Prevention (CDC) reports that the chemicals are present in the urine of about 75 percent of Americans.

Dr. Rolf Halden, director of the Center for Environmental Security at Arizona State University, has followed the issue for years and says, “These chemicals interfere with the regulation of the human body.” Halden noted that the chemicals accumulate in ground water and soil, and that one study of human breast milk found the chemicals in the milk of 97 percent of the women tested, according to the Times. “The fascinating thing is the public has not taken note of this issue.”